Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K943919 |
Device Name |
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Applicant Contact |
PAMELA L PAPINEAU |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Correspondent Contact |
PAMELA L PAPINEAU |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 08/12/1994 |
Decision Date | 03/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|